80 FR 20235 - Innovations in Medical Evidence Development and Surveillance-Methods Research Agenda

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 72 (April 15, 2015)

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of Center for Drug Evaluation and Research (CDER). The goal of the CDER is to support the development of appropriate methodologies to conduct medical product safety surveillance in large electronic databases. Innovations in Medical Evidence Development and Surveillance (IMEDS)-Methods is a program within the Reagan-Udall Foundation that supports FDA's scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases.

[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20235-20236]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08613]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1083]


Innovations in Medical Evidence Development and Surveillance-
Methods Research Agenda

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of Center for Drug 
Evaluation and Research (CDER). The goal of the CDER is to support the 
development of appropriate methodologies to conduct medical product 
safety surveillance in large electronic databases. Innovations in 
Medical Evidence Development and Surveillance (IMEDS)-Methods is a 
program within the Reagan-Udall Foundation that supports FDA's 
scientific mission of serving public health needs by initiating and 
facilitating research into the methods of safety evaluation in large 
databases.

DATES: 1. The application due date is June 15, 2015.
    2. The anticipated start date is July 15, 2015.
    3. The opening date is April 13, 2015.
    4. The expiration date is June 16, 2015.

ADDRESSES: Submit the electronic application to: http://www.grants.gov. 
For more information, see section III of the SUPPLEMENTARY INFORMATION 
section of this notice.

FOR FURTHER INFORMATION CONTACT: Patrick Archdeacon, Food and Drug 
Administration, Bldg. 51 Rm.6314, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 301-796-3952; or Vieda Hubbard, Division of 
Acquisition Support and Grants (HFA-500), Food and Drug Administration, 
5630 Fishers Lane, Rockville, MD 20857, 240-402-7588.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at: http://www.grants.gov/.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-15-010 93.103

A. Background

    Section 905 of the Food and Drug Administration Amendments Act of 
2007 (Pub. L. 110-85) mandates FDA to develop an enhanced ability to 
monitor the safety of drugs after these products reach the market. In 
response to this mandate, FDA launched its Sentinel Initiative, a long-
term program designed to build and implement an electronic system for 
monitoring the safety of medical products in the post market setting. 
FDA has already created significant infrastructure on which to operate 
such a system: Through its Mini-Sentinel pilot, a distributed database 
with access to more than 150 million patient records has been created 
(the Sentinel Distributed Database). In order to optimally leverage 
these data, however, new analytic methodologies will be required. 
IMEDS-Methods is a program within the Reagan-Udall Foundation that 
supports FDA's scientific mission of serving public health needs by 
initiating and facilitating research into the methods of safety 
evaluation in large databases. IMEDS-Methods aims to improve the tools 
for conducting post-marketing safety surveillance using automated 
healthcare data and to foster their adoption.

B. Research Objectives

    IMEDS plans to conduct methods research in five core areas: (1) 
Addressing bias in estimates from observational studies; (2) better 
understanding uses and limitations of the data; (3) applying lessons 
learned from earlier IMEDS projects to FDA surveillance activities; (4) 
expanding the surveillance question to continuous risk/benefit 
assessment; and (5) continuing to support qualified investigators in 
industry, government, and academic settings by providing access to de-
identified electronic healthcare data and computing resources through 
the IMEDS Research Laboratory.

C. Eligibility Information

    Eligibility is limited to the Reagan-Udall Foundation. The Reagan-
Udall Foundation has established the IMEDS-Methods program, which is 
uniquely positioned to develop the new methodologies required for FDA 
to conduct effective active post market safety surveillance of medical 
products using large electronic health care data. The IMEDS 
organization has developed a network of statisticians, epidemiologists, 
data scientists, and clinicians who have experience operating in both 
the IMEDS research laboratory and also familiarity with the Sentinel 
Distributed Database. In addition, through the Reagan-Udall Foundation 
public-private partnership, the IMEDS-Methods program has a unique 
ability to convene FDA, patients, academics, government, and industry 
so that the findings and tools developed through its research agenda 
will be promulgated and adopted.

II. Award Information/Funds Available

A. Award Amount

    FDA/CDER intends to fund up to $1,000,000 in fiscal year 2015 in 
support of this program project. It is anticipated that only one award 
will be made, not to exceed $1,000,000 (direct plus indirect) for total 
costs.

B. Length of Support

    There is a one year period of performance beginning on June 15, 
2015 or the date of award.

III. Electronic Application, Registration, and Submission

    Only one electronic application will be accepted. To submit an 
electronic application in response to this FOA, the applicant should 
first review the full announcement located at http://www.grants.gov/. 
(FDA has verified the Web site addresses throughout this document, but 
FDA is not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)
    For the electronically submitted application, the following steps 
are required.
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number
     Step 2: Register With System for Award Management (SAM)
     Step 3: Obtain Username & Password

[[Page 20236]]

     Step 4: Authorized Organization Representative (AOR) 
Authorization
     Step 5: Track AOR Status
     Step 6: Register With Electronic Research Administration 
(eRA) Commons
    Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in 
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed 
these steps, submit the electronic application to: http://www.grants.gov.

    Dated: April 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08613 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P